United States ex rel. Cheryl Eckard v. GlaxoSmithKline Safeguarding cGMP Compliance for Patients and the Public Lesley Ann Skillen, Getnick & Getnick LLP | Counsellors At Law Rockefeller Center, 620 Fifth Avenue | New York, NY Phone: (212) | Fax: (212) |

The False Claims Act Qui Tam Law  Creates a civil cause of action for fraud on the government.  Allows an action to be brought both by the government and by a private citizen in the name of the government (the qui tam “relator”).  Relator is entitled to receive up to 30% of the proceeds plus attorneys fees and costs.

The False Claims Act Qui Tam Law  Passed by the Lincoln Administration in  Strengthened by the Reagan Administration in 1986 and the Obama Administration in 2009 /  The qui tam law is “firmly rooted in the American legal tradition.”  The qui tam law is a “public-private partnership.”

Recoveries for Taxpayers Total qui tam recoveries since 1986 $18 billion Total qui tam recoveries from pharma companies since 2000 $11 billion

A New Role for the Qui Tam Law: Safeguarding cGMP Compliance  U.S. ex rel. Eckard v. GlaxoSmithKline and SB Pharmco Puerto Rico, 04 CV10375 (JLT) (D.Mass.)  GSK agreed to pay $750 million to the United States and the 50 States  GSK subsidiary SB Pharmco pled guilty to distributing adulterated drug products

Relator, Plant and Products  Relator: Cheryl Eckard, GSK Global Quality Assurance  Plant: Cidra, Puerto Rico.  $5.5 billion annually  Products: Solid oral dosage forms (Paxil, Avandia, Avandamet, Coreg and others), creams, ointments, injectibles and suspensions.

Areas of Non-Compliance Reported to Management  Areas of “high risk” reported April 2003:  Mix-ups  Validation  Investigations  Sterile manufacturing  Documentation quality  Microbial contamination in water system and manufacturing areas

Termination and Report to Compliance Department  April 2003 reported chronic super-and sub-potency in Avandamet since product launch and suggested possible recall  Terminated May 2003  Attempted report to CEO, General Counsel  Report to Compliance Department, June-October 2003

Report to FDA and Qui Tam Case  GSK Compliance Dept finding: “unsubstantiated”  Report to FDA - Search Warrants  FDA inspection and 483 issued Dec 2003  Qui tam filed February 2004  FDA inspection and 483 issued Nov 2004  Largest seizure of drug products in FDA history and Consent Decree 2005  $750 million settlement 2010

Qui Tam Allegations  Mix-ups and lies to FDA in FARs  Microbial contamination in products, in the water system and in manufacturing areas, including the sterile facility  Content uniformity failures not corrected  Products and processes not validated  Investigations overdue, inadequate: lab, process and complaint  Thousands of instruments not calibrated  Chronic documentation deficiencies  HVAC deficient/cross contamination

Civil Settlement and Criminal Plea  $600 million civil settlement resolved allegations that GSK sold the government four products that were adulterated: Bactroban, Kytril, Avandamet and Paxil CR  $150 million criminal fine and guilty plea: releasing batches of those products in interstate commerce with intent to defraud and mislead

cGMPs and CFRs Cited in Criminal Plea  Quality Unit  Contamination and product mix-ups  Equipment (calibration, inspection, maintenance)  In-process testing  End-product testing  Batch records  Investigations  Field Alert Reports  Annual Reports

cGMP Non-Compliance and False Claims Act Liability  Substantial compliance with the cGMPs is material to the government’s decision to pay  Drug approvals were obtained via false representations to the FDA  Drugs did not come with the assurance of strength, purity, quality and identity represented in the NDA  Criminal Information also sounds this theme

False Claims Act Damages  FCA damages are recoverable for the full value of product sold to the government where the government paid for quality assurance that it did not receive  Breakdown of Quality System at Cidra  FCA provides for treble damages  Government does not have to “trace bad batches”

Lessons  Drug manufacturing is complex, opaque and rife with opportunities for cGMP non-compliance  Consumers must rely on drug makers to police themselves  cGMP compliance is now open to the scrutiny of whistleblowers  Quality managers and others are empowered to ensure that production does not take precedence over quality

Questions? Getnick & Getnick LLP | Counsellors At Law Rockefeller Center, 620 Fifth Avenue | New York, NY Phone: (212) | Fax: (212) |